Magnetic Nanoparticles System in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

The Development and Clinical Application of Rapid Assays Using Multi-antibody-activated Magnetic Nanoparticles System in Acute Coronary Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02226523
• Other study ID #: 103002_N_103CT1026
• Status: Active, not recruiting
• Start date: February 2014
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To improve the sensitivity and specificity of immunoassay, the developing trends are to lower the detection threshold and to minimize the cross reaction. A new assay technology called immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with small volume of sample. Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and operational priority in busy emergency departments (ED), early and correct diagnosis is important. Cardiac enzymes (including CPK/CK-MB, troponins, myoglobulin) and electrocardiography (ECG) in combination with the medical history and physical examination are at present the diagnostic cornerstones. Novel biomarkers that rise earlier, have good diagnosis accuracy and have additional prognostic information are highly needed. The combination of multiple biomarker assays (markers of myocardial injury, inflammation/plaque ruptures or heart failure with different mechanism) may increase clinical sensitivity and improve early risk stratification. The present study, a rapid IMR assay with multiple biomarkers is proposed and we will examine the performance of this new investigational IMR assays, comparison with current commercial assays.

Description:

To improve the sensitivity and specificity of immunoassay, the developing trends are to lower the detection threshold and to minimize the cross reaction. A new assay technology called immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with very small volume of sample (i.e. less than 1ml whole blood). The reagent is a solution of homogeneously dispersed magnetic nanoparticles, which are coated with hydrophilic surfactants and bioprobes. Under external multiple alternating-current (ac) magnetic fields, magnetic nanoparticles oscillate with the multiple ac magnetic fields via magnetic interaction. The reagents under the external multiple ac magnetic fields show a magnetic property, called mixed-frequency ac magnetic susceptibility χac. Magnetic nanoparticles bind with the bioprobes on the outmost shell and become larger or clustered. The χac of the reagent is reduced, and the concentration of the biomolecules can be measured quantitatively. Several papers have demonstrated that IMR can be applied to assay proteins, viruses, chemicals, and nucleic acids once suitable bioprobes are immobilized onto the magnetic nanoparticles.

Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and operational priority in busy emergency departments (ED). Since ACS is associated with a significant mortality and morbidity, early and correct diagnosis is of great importance. Chest pain is a frequent symptom in medical emergency departments and distinguishing patients with ACS within the chest pain group is a diagnostic challenge. Cardiac enzymes (including CPK/CK-MB, troponins, myoglobulin) and electrocardiography (ECG) in combination with the medical history and physical examination are at present the diagnostic cornerstones. Different cardiac enzymes are released after myocardial cell disintegration and are markers of cell necrosis, which might not be detected immediately after chest pain; and repeated measurements are suggested. Therefore novel biomarkers that rise earlier, have good diagnosis accuracy and have additional prognostic information are highly needed. Some publications address the potential benefit of the combination of multiple biomarker assays (markers of myocardial injury, inflammation/plaque ruptures or heart failure with different mechanism) could substantially increase clinical sensitivity and improve early risk stratification. However, this approach is rather time-consuming and not cost-effect. In the present study, a rapid IMR assay with multiple biomarkers is proposed and we will examine the performance of this new investigational IMR assays, comparison with current commercial assays.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 455
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diagnosis with acute coronary syndrome

Exclusion Criteria: none

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taoyuan General Hospital, Ministry of Health and Welfare	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prediction of MACEs by rapid IMR system	Evaluation of prognostic significance of multi-antibody-activated magnetic nanoparticles system (troponin, CK-MB, myoglobin, BNP, CRP, adipocyte fatty-acid binding protein/FABP-4) in acute coronary syndrome	6 months
Primary	Diagnositic accuracy of acute myocardial infarction	Evaluation of the diagnostic performance of rapid IMR assays in detection of acute myocardial infarction; Cardiac enzymes (CPK/CK-MB, troponins), electrocardiography in combination with the symptoms of typical chest pain are at present the diagnostic gold standard.	7 days
Secondary	Combination of potential biomarkers in detection of ACS by rapid IMR system	Compared to cardiac enzymes (CK/CK-MB, troponin), the diagnostic performance of combination of new biomarkers (BNP, FABP4, CRP, etc.) in detection of ACS by rapid IMR system	7 days